Data from its First Pediatric Study are Anticipated in the Second Half of 2019.
CAMBRIDGE, Mass. /PRNewswire/ -- AOBiome Therapeutics, Inc. ("AOBiome"), a leading clinical-stage microbiome company focusing on the research and development of therapeutics for dermatological conditions, migraine, hypertension and other systemic diseases, today announced the administering of its lead product candidate, B244, to the first patient in the Company's Phase 1b clinical trial to treat pediatric patients with atopic dermatitis (eczema).
The clinical trial is an open-label, multicenter, Phase 1b study of B244, a first-in-class, topical formulation of beneficial ammonia oxidizing bacteria ("AOB"), delivered as a topical spray twice daily and is designed to assess safety and tolerability in 36 pediatric patients aged 2 to 17 years with mild to moderate atopic dermatitis over a 28-day period.
"There is a significant medical need for new therapies to treat children with atopic dermatitis due to the high and increasing incidence of the disease and the limited number of safe and efficacious options to treat this sensitive population," said President & CEO, Todd Krueger. "We look forward to announcing results from this study in the second half of 2019."
In the United States, 13% of children (or 9.6 million) under the age of 18 years suffer from eczema.1 Of these, approximately one third have moderate to severe eczema. Additionally, many children who suffer from atopic dermatitis in their youth also go on to disproportionally suffer from certain diseases later in life, including 43% of children with severe atopic dermatitis before the age of 8 developing asthma and 45% developing allergic rhinitis according to one recent study.2
"Our goal is to alleviate both the symptoms that are associated with atopic dermatitis and to utilize AOB's nitric oxide-mediated anti-inflammatory abilities coupled with its capability to reduce levels of pathogenic bacteria as a dual-modality approach to treatment," said Chief Medical Officer, Dr. Judith Ng Cashin, M.D. "Current therapies for atopic dermatitis can cause side effects such as stinging, burning, and thinning of skin, especially in pediatric patients. B244's innovative nature represents a novel therapeutic opportunity to address the significant market need and to impact the lives of patients."
In addition to the ongoing pediatric study, AOBiome is currently conducting a Phase 2 clinical trial investigating B244 for the treatment of adult atopic dermatitis with expected top-line data readout in 2019.
Additional information regarding this and AOBiome's other ongoing clinical programs may be found at www.clinicaltrials.gov.
About Ammonia Oxidizing Bacteria (AOB)
AOBiome's AOB platform is a patented, proprietary, topical and intranasal formulation incorporating a single strain of beneficial AOB, Nitrosomonas eutropha. The platform is designed to repopulate the skin or nasal microbiome with AOB. Once deployed, AOB produces nitric oxide, a signaling molecule known to regulate inflammation and vasodilation.
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1 Hanifin J, Reed M. A Population-Based Survey of Eczema Prevalence in the United States. Dermatitis. 2007;18(2):82-91. doi:10.2310/6620.2007.06034.
2 Gustafsson, D., et al. "Development of Allergies and Asthma in Infants and Young Children with Atopic Dermatitis – a Prospective Follow‐up to 7 Years of Age." The Canadian Journal of Chemical Engineering, Wiley-Blackwell, 9 Oct. 2008, onlinelibrary.wiley.com/doi/abs/10.1034/j.1398-9995.2000.00391.x.